Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 8, 2024 Endolumik % Michael Nilo President Nilo Medical Consulting Group 3706 Butler Street, #313 Pittsburgh, Pennsylvania 15201 Re: K240069 > Trade/Device Name: Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT. FAT Dated: January 8, 2024 Received: January 9, 2024 Dear Michael Nilo: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2}------------------------------------------------ Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Anthony Lee -S Anthony C. Lee, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K240069 Device Name Endolumik Gastric Callbration Tube M Series (EGCT36M): Endolumik Gastric Calibration Tube M Series (EGCT40M) Indications for Use (Describe) The EndolumikGastric Calibration Tube is indicated for use in gastric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids,irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | Prescription Use (Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use (21 CFR 801 Subpart C) | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ K240069 Page 1 of 2 ### Contact Details # 510(k) Summary 21 CFR 807.92(a)(1) Prepared on: 2024-01-08 | Applicant Name | ENDOLUMIK | |---------------------------------|------------------------------------------------------------| | Applicant Address | 364 Patteson Dr. #293 Morgantown WV 26505 United States | | Applicant Contact Telephone | 510.468.4426 | | Applicant Contact | Mrs. Mara McFadden | | Applicant Contact Email | mcfadden@endolumik.com | | Correspondent Name | Nilo Medical Consulting Group | | Correspondent Address | 3706 Butler Street, #313 Pittsburgh PA 15201 United States | | Correspondent Contact Telephone | 717.421.4396 | | Correspondent Contact | Mr. Michael Nilo | | Correspondent Contact Email | michael.nilo@nilomedicalconsulting.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | |---------------------|--------------------------------------------------------------------------------------------------------------| | Common Name | Gastrointestinal tube and accessories | | Classification Name | Tubes, Gastrointestinal (And Accessories) | | Regulation Number | 876.5980 | | Product Code(s) | KNT, FAT | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|----------------------------------------------------------|--------------| | K222880 | Endolumik Gastric Calibration Tube | KNT | Device Description Summary 21 CFR 807.92(a)(4) The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in esophageal, gastric, and bariatric surgery. It may be used for the following: the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position. The Endolumik Gastric Calibration Tube is a non-sterile, single patient use device. The tube is 80 cm long and is available in 2 different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end. The proximal end includes a handle with an integral suctionregulator. An additional squeeze bulb with pressure gauge may be attached to the end of the {5}------------------------------------------------ ### Intended Use/Indications for Use The EndolumikGastric Calibration Tube is in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids,irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position. ## Indications for Use Comparison The Indications for Use between the currently marketed predicate device and the subject device are identical. The predicate device Indications for Use were updated after clearance to include identification as an esophageal bougie as this is a Class I indication which did not require a new 510(k). ### Technological Comparison The proposed Endolumik M Series Gastric Calibration Tube is identical to the predicate device with the previously cleared EGCT36 models utilized LEDs of wavelengths between 697 - 766nm, which is in the visible range of the Near Infrared (NIR) spectrum. The M models utilize LEDs between wavelengths 766 and 920nm. These wavelengths are also in the NIR spectrum, and are designed for use with NIR cameras that can only visualize NIR light between 800-900nm. However, these proposed wavelengths are not visible to the human eye, so one additional 520nm (green visible light) LED was added to give users a positive indication that the product had been powered on. #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The following tests were performed to evaluate the substantial equivalence. All tests passed. IEC 60601-2 IEC 60601-2 Section 5 IEC 60601-1 IEC 60601-2-18 IEC 6247 1 21 CFR 807.92(a)(5) 21 CFR 807.92(a)(5) # 21 CFR 807.92(a)(6)